Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence

NCT02334878 | Completed Phase 3

• 1 other identifier: FMASU 3098/2014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of mesenchymal stem cells in treatment of stress urinary incontinence due to intrinsic sphincter deficiency; in which the problem is weakness or damage of the sphincter muscle responsible for continence. Mesenchymal stem cells are undifferentiated cells which can undergo self-renewal \& differentiation into other cell types like muscle cells; thus can be used to regenerate the damaged sphincter muscles. In this study mesenchymal stem cells will be obtained from bone marrow from the patient, processed, \& then re-injected periurethrally. Effectiveness will be compared to that of the surgical treatment (tension-free vaginal tape).

Conditions

Urinary Incontinence, Stress

Keywords

Stem Cells; Mesenchymal

Outcome Measures

Primary Outcomes (1)

• change in cough test & urodynamic study as a measure of efficacy of treatment

  cough test: as positive or negative leakage with cough. Urodynamic study: changes in abdominal leak point pressure, and changes in maximum urethral closure pressure

  before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection).

Secondary Outcomes (1)

• Quality of life as measured by the Incontinence Quality of Life (I-QOL) Instrument Score

  before & after therapy each 3 months for one year (at 3m, 6m, 9m, 12m post-injection).

Study Arms (2)

Stem cells,Mesenchymal

EXPERIMENTAL

Periurethral injection of autologous bone-marrow derived stem cells.

Biological: Stem Cells,Mesenchymal

surgery (TVT)

ACTIVE COMPARATOR

Tension-free vaginal tape operation: a midurethral sling operation

Procedure: surgery (TVT)

Interventions

Stem Cells,Mesenchymal BIOLOGICAL

The patient will be placed in lithotomy position. A Foley's catheter (size 18) will be inserted in the urethra, then under local anaesthesia; retrieved cells (total 20- 30 million cells per patient in 10cc syringe) will be injected into the submucosal tissue at the level of the proximal urethra just distal to the bladder neck (guided by stretch on the Foley's catheter), at 3,9,12 o'clock, injecting around 3.5 cc in each site.

Stem cells,Mesenchymal

surgery (TVT) PROCEDURE

A small midurethral incision will be made in the vaginal mucosa, then a polypropylene 40\*1cm mesh tape attached to two curved trocars will be passed lateral to the urethra \& through the endopelvic fascia into the retropubic space. The trocar will then be passed along the back of the pubic bone, through the rectus fascia, in two small suprapubic skin incisions, then the tension on the tape adjusted \& the remaining tape cut off at the level of the skin.

surgery (TVT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of stress urinary incontinence
• Urodynamic study showing stress urinary incontinence due to intrinsic sphincter deficiency

You may not qualify if:

• Pregnant females
• Hypermobility of the urethra
• Mild cases (treatment is mainly physiotherapy \& pelvic floor exercises)
• Urge incontinence / Urodynamic study showing detrusor instability
• Current urinary infection
• Current severe cystocele or rectocele
• History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
• Voiding dysfunction (post-void residual volume \>100cc)

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Maternity hospital, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed A El-Nazer, PhD

  Ain Shams University Maternity Hospital

  STUDY CHAIR

• Abdel-Latif G El-Kholy, PhD

  Ain Shams University Maternity Hospital

  STUDY DIRECTOR

• Mostafa F Gomaa, PhD

  Ain Shams University Maternity Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: January 8, 2015
• Study Start: October 1, 2015
• Primary Completion: October 30, 2016
• Study Completion: December 1, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)